Digital cognitive behavioral therapy for inSomNia symptOms in pRegnant womEn with psychiatric vulnerability: a prospective cohort study

Insomnia symptoms are highly prevalent during pregnancy with an overall
prevalence of 38,2 percent. Research has shown that insomnia during pregnancy
is associated with an increased risk of preterm birth, perinatal depression,
suicidality, and anxiety disorders. Prenatal stress, anxiety and depression
also influence fetal development, birth outcome and child development.
Cognitive behavioral therapy for insomnia (CBT-I) has been proven effective in
pregnancy for insomnia symptoms with also a positive effect on depressive- and
anxiety symptoms. Unfortunately, there is limited access to CBT-I-trained
clinicians, resulting in a lack of treatment of insomnia or treatment with off
label medication. Digital CBT-I (dCBT-I), has been developed to grant easy
access to insomnia treatment, is widely used and proven effective in the
general population. Results for the use in pregnant women are promising, but up
until now psychiatrically vulnerable women have been excluded in previous
studies. Hence, there is an utmost urgency to gain more knowledge on the
effectiveness of insomnia interventions during pregnancy for women with known
psychiatric vulnerability and to implement effective programs in standard
gynecological care to improve maternal-fetal outcome.

1. Provide evidence for the clinical effectiveness of dCBT-I for the treatment
of insomnia symptoms in pregnant woman with psychiatric vulnerability.
2. Provide evidence for the effectiveness of insomnia treatment and the
positive effects on mental health for pregnant women who already struggle with
psychiatric vulnerability.

a prospective cohort design. N=76

CBT-I is a form of evidence-based psychotherapy with a focus on behaviour,
thoughts, emotions and their corelation regarding sleep. The digital
intervention consists of six modules with explanatory text, videos, figures and
exercises. Patients will be asked to finish the modules within seven weeks.
However, there will be a possibility of extending this period if needed. This
extension beyond seven weeks will be documented. Patients can access their
intervention from several digital devices such as mobile phones, tablets and
personal computers. It works in every main browser available to date. Patients
are free to choose when and where they want to complete the module. The
intervention is self-guided, so patients will not receive any feedback from a
health-care professional.

Risks: Patients will not be exposed to additional risks due to this treatment.
Patients and treating physicians are free to treat psychiatric symptoms to
their best knowledge. No restrictions are given to the patients participating
in this trial.
Patients who do not want to participate in this trial will receive
care-as-usual from the psychiatrist of the POP outpatient center and their
general practitioner and/or other caregiver.

Burden: Time: Filling in questionnaires (3 x 30 min), completing the online
module (6 sessions of 1-2 hours).
Sleepwatch and sleep diary: patients have to wear a watch-sized actimeter on
their wrist two times: at baseline (T0) for 7 days and after treatment (T1) for
7 days. So 14 days in total. Patients fill in a sleep diary simultaneously that
will take 2 minutes every day.

Benefits: An easy to use, patient friendly low intensive treatment to develop
coping skills for insomnia problems.